Public Confidence and Involvement in Clinical Research
Symposium Summary Clinical Research Roundtable September 2000
Andrea L. Kalfoglou,
Program Officer
Douglas A. Boenning,
Senior Program Officer
Mary Woolley,
Symposium Coordinator
Board on Health Sciences Policy
INSTITUTE OF MEDICINE
Washington, D.C.
INSTITUTE OF MEDICINE
2101 Constitution Avenue, N.W. Washington, DC 20418
NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.
Support for this project was provided by the AMA, AAMC, AHRQ, VA, CDC, FDA, NIH, RWJ, Blue Cross/Blue Shield, Johnson & Johnson, Burroughs Wellcome Fund, Merck and Co., Pfizer, Inc., and the Doris Duke Charitable Foundation. The views presented in this report are those of the Institute of Medicine Clinical Research Roundtable and are not necessarily those of the funding agencies.
Additional copies of this report are available in limited quantities from the Board on Health Sciences Policy, 2101 Constitution Avenue, N.W., Washington, D.C. 20418. Call (202) 334-2653. The full text of this report is available at www.nap.edu.
For more information about the Institute of Medicine , visit the IOM home page at www.iom.edu.
Copyright 2001 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America.
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THE NATIONAL ACADEMIES
National Academy of Sciences
National Academy of Engineering
Institute of Medicine
National Research Council
The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences.
The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. William A. Wulf is president of the National Academy of Engineering.
The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine.
The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.
Clinical Research Roundtable
WILLIAM GERBERDING, (Chair),
President Emeritus, University of Washington, Seattle, Washington
TOM BEAUCHAMP, Professor of Philosophy and Senior Research Scholar,
Kennedy Institute of Ethics, Georgetown University, Washington, D.C.
ENRIQUETA BOND, President,
Burroughs Wellcome Fund, Research Triangle Park, North Carolina
VERONICA CATANESE, Associate Dean,
New York University School of Medicine,
Director of Development,
American Federation for Medical Research Foundation, New York, New York
FRANCIS CHESLEY, Director,
Office of Research, Review, Education and Policy, Agency for Healthcare Research and Quality, Rockville, Maryland
WILLIAM F. CROWLEY, JR., Professor of Medicine,
Harvard University,
Director of Clinical Research,
Massachusetts General Hospital, Boston, Massachusetts
ADRIAN DOBS, Associate Professor of Medicine, Director,
Clinical Research Unit, Johns Hopkins University School of Medicine, Baltimore, Maryland
JOHN FEUSSNER, Chief Research and Development Officer,
Department of Veterans’ Affairs, Washington D.C.
MYRON GENEL, Associate Dean,
Office of Government and Community Affairs, Yale University School of Medicine, New Haven, Connecticut
KENNETH GETZ, President/Publisher,
CenterWatch, Boston, Massachusetts
JACK GREBB, Senior Vice President,
Research and Development, Janssen Research Foundation, Titusville, New Jersey Johnson & Johnson, Global CNS/Analgesia Clinical
STEPHEN KATZ, Director,
National Institute of Arthritis and Musculoskeletal and Skin Diseases,
Chief,
Dermatology Branch, National Cancer Institute, Bethesda, Maryland
ALLAN M. KORN, Senior Vice President, Chief Medical Officer,
Blue Cross/Blue Shield Association, Chicago, Illinois
DAVID KORN, Senior Vice President for Biomedical and Health Sciences Research,
Association of American Medical Colleges, Washington D.C.
ELAINE L. LARSON, Professor of Pharmaceutical and Therapeutic Research,
Columbia University School of Nursing, New York, New York
MARY LERCHEN, Director,
Prevention Research and Academic Partnerships, Center for Disease Control and Prevention, Atlanta, Georgia
E. ALBERT REECE, Abraham Roth Professor and Chairman,
Department of Obstetrics, Gynecology, and Reproductive Sciences, Temple University School of Medicine, Philadelphia, Pennsylvania
DAVID L. RIMOIN, Chairman of Pediatrics and Director,
Medical Genetics-Birth Defects Center Cedars-Sinai Medical Center, Los Angeles, California
PATRICIA SALBER, Medical Director for Managed Care Health Care Initiative,
General Motors Co., The Permanente Company, Larkspur, California
LEWIS SANDY, Executive Vice President,
Robert Woods Johnson Foundation, Princeton, New Jersey
DAVID SCHEINBERG, Doris Duke Clinical Science Professor Chief,
Leukemia Service, Memorial Sloan-Kettering Cancer, New York, New York
BERNARD SCHWETZ, Acting Deputy Commissioner and Senior Advisor for Science, Food and Drug Administration,
Rockville, Maryland
LOUIS SHERWOOD, Senior Vice President for Medical and Scientific Affairs,
Merck and Co., West Point, Pennsylvania
WILLIAM SIGMUND, Vice President for Medical Affairs,
Pfizer Pharmaceuticals Group, Pfizer, Inc., New York, New York
LANA SKIRBOLL, Director,
Office of Science Policy, National Institutes of Health, Rockville, Maryland
HAROLD SLAVKIN, Dean,
G. Donald and Marian James Montgomery Professor of Dentistry, School of Dentistry, University of Southern California, Los Angeles, California
MYRL WEINBERG, President,
National Health Council, Washington D.C.
MICHAEL J. WELCH, Co-Director,
Division of Radiological Sciences, The Edward Mallincrodt Institute of Radiology, Washington University School of Medicine, St. Louis, Missouri
Liaisons to the Roundtable
DAVID BLUMENTHAL,
Liaison to the Board on Health Sciences Policy;
Director,
Institute for Health Policy, Massachusetts General Hospital/Partners HealthCare System
STEVEN PAUL,
Liaison to the Board on Neuroscience and Behavioral Health;
Vice President,
Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center
HUGH TILSON,
Liaison to the Board on Health Promotion and Disease Prevention;
Senior Advisor to the Dean,
School of Public Health, University of North Carolina, Global Health Outcomes, Glaxo Wellcome Company
MARY WOOLLEY,
Liaison to the Board on Health Sciences Policy;
President,
Research! America
Study Staff
ANDREW M. POPE, Director,
Board on Health Sciences Policy
ALEX OMMAYA, Project Director (May 2001-Current)
ANDREA KALFOGLOU, Program Officer
DOUGLAS BOENNING, Project Director (June 2000-March 2001)
CURT TAYLOR, Senior Project Assistant (July 2000-March 2001)
Contributing Staff
FREDERICK J. MANNING, Senior Program Officer
CHARLES EVANS, Senior Advisor for Biomedical and Clinical Research
ALDEN CHANG, Administrative Assistant
REVIEWERS
The report was reviewed by individuals chosen for their diverse perspectives and technical expertise in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments to assist the authors and the Institute of Medicine in making the published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The content of the review comments and the draft manuscript remain confidential to protect the integrity of the deliberative process. The committee wishes to thank the following individuals for their participation in the report review process:
Bernard A. Schwetz, Acting Deputy Commissioner of Food and Drugs, Food and Drug Administration, Rockville, Maryland
Hugh Tilson, Liaison to the Board on Health Promotion and Disease Prevention; Senior Advisor to the Dean, School of Public Health, University of North Carolina, Global Health Outcomes, Glaxo Wellcome Company
Mel Worth, M.D., Scholar-in-Residence, Institute of Medicine, Washington, D.C.
While the individuals listed above provided many constructive comments and suggestions, responsibility for the final content of the report rests solely with the authoring committee and the Institute of Medicine.